Pre-clinical testing of the vaccine candidate at UAB in 2020. Credit: UAB

Altimmune Inc.’s vaccine candidate, which was preclinically tested last year at the University of Alabama, Birmingham, is expected to begin enrollment for its Phase 1 clinical trial next week.

Maryland-based biopharmaceutical company Altimmune announced that the US Food and Drug Administration has approved the company’s Investigational New Drug application for its Phase 1 clinical trial of AdCOVID, a novel single-dose intranasal COVID-19 vaccine candidate Has.

AdCOVID’s UAB preclinical tests last spring and summer were conducted by Dr. Fran Lund, Chairman of UAB’s Microbiology Department. 23 other researchers from six UAB laboratories at the UAB School of Medicine were working strictly on COVID-19 safety protocols, which required masking and social distancing. The UAB researchers found strong serum-neutralizing antibody responses, T-cell responses, and robust induction of mucosal immunity in mice after a single intranasal dose of AdCOVID.

The vaccine candidate has tantalizing promises, according to Altimmune. No cooling necessary. Easy one-time administration through a spray in the nose. The ability to induce mucosal immunity on the linings of the nose and lungs would protect not only from infection but also from transmission. Existing COVID-19 intramuscular vaccines are not known to induce this type of immunity.

Altimmune believes that these simple and convenient handling requirements, combined with the potential ability to block SARS-CoV-2 transmission, could position AdCOVID as the premier intranasal COVID-19 vaccine.

“We believe the use of intranasal vaccines like AdCOVID will be critical to a successful global response to the pandemic,” said Dr. Vipin K. Garg, President and CEO of Altimmune. “Developing vaccines that can effectively prevent transmission is a growing need to block the spread of disease and control the emergence of new variants.”

Altimmune’s Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy volunteers between the ages of 18 and 55 years. AdCOVID is given as a nasal spray in one of three doses. Altimmune will primarily pay attention to safety and tolerability, but will also measure the immunogenicity of AdCOVID through serum IgG binding and neutralizing antibody titers, mucosal IgA antibodies from nasal samples and T cell responses.

Lund said of last year’s preclinical testing, “In animals, intranasal vaccination triggered immune responses to the SARS-CoV-2 virus in the nose and lungs, which are the sites where the virus first becomes infected.

“If the vaccine works similarly in humans, we hope that vaccination via the intranasal route will not only protect the person vaccinated from serious illnesses, but will also help minimize virus transmission within the community. We look forward to the first data human studies. ”

Preclinical study of the COVID-19 vaccine candidate shows strong T-cell responses provided by the University of Alabama in Birmingham

Quote: The COVID-19 vaccine candidate tested at UAB will start the clinical phase 1 study (2021, February 19), which will be launched on February 20, 2021 at vaccine-candidate-uab- retrieved. phase.html

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